Regulatory Affairs Specialist Contractor (Alger)

Publication date: Jan 11, 2023

Function: Hospitals / Pharmaceuticals
Nb position : 1
Types of contracts: Fixed term contract
Academic level : > bachelor level +5
Experience : 3 to 4 years

« Cette offre d'emploi a expirée »

Missions

For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
Secures for assigned authorized products timely submission and follow-up of variations, renewal applications, and supplemental marketing authorizations.
For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.
Ensures permanent compliance to local regulatory requirements and to comapany’s policies and procedures.
Demonstrates clear leadership in shaping the regulatory environment to support Subsidiary’s objectives.
Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives.
Ensures commercial shipments release by sending appropriate documents to distributors in a timely manner.
Liaises with different stakeholders (manufacturing sites, distributorsetc.) and ensures release dossier conformity to HAs requirements.
Coordinates labeling activities and Collaborates closely with Registration Managers in order to ensure timely submission.
Ensures updates to all regulatory databases.
Supports local business with promotional materials and events review and submission.
Works in cross-functionality with local departments: Supply, Market Access, Business, Medical Finance, etc.
Maintains a positive relationship with internal and external regulatory contacts.
Ensures permanent compliance to local regulatory requirements and to internal policies and procedures.
Ensures administrative support to the Regulatory Department with internal and external stakeholders (Finance Department, vendors ..etc).